Despite marketing approval of two oligonucleotide drugs, there is no regulatory guideline that specifically addresses the quality expectations for this class of therapeutics. This workshop addresses the application of existing FDA and ICH quality guidelines to the successful chemical and pharmaceutical development of oligonucleotide therapeutics in the US, Canada and Europe.

Chemical, pharmaceutical and analytical development of peptides continues to be challenging due to the increased complexities of development programs and an evolving regulatory landscape. As contract organizations are a major part of most development efforts, it is becoming increasingly important to consider business issues such as intellectual property, know how, confidentiality and other factors when choosing a manufacturing partner as these factors impact downstream development such as site/process changes; business development; licensing, etc. This workshop will present strategies and case studies for managing the business aspects of process and analytical development for commercial and regulatory success.

Throughout the drug development process, the active ingredient and drug product formulation should be characterized to a clinical phase-appropriate extent. This course provides background on several of the more common characterization categories and techniques applicable to oligonucleotides and peptides, followed by detailed case studies. Because the course covers a broad range of topics and discussion is encouraged, most development scientists will be able to contribute from their own experience in some areas and learn entirely new material in other areas, based on their own expertise and background. The material is fairly detailed, and so is especially applicable to bench scientists and their direct supervisors. It is intended to be a primer to the main TIDES meeting and should be especially valuable to newcomers to the TIDES venue.